Nano-Based Food and Substantial Equivalence: A Category-Mistake

Nano-Based Food and Substantial Equivalence: A Category-Mistake

Jenna Woodrow (Thompson Rivers University, Canada) and Michael D. Mehta (Thompson Rivers University, Canada)
DOI: 10.4018/jnmc.2010070103
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In recent years regulators have become sensitized to the fact that advances in nanotechnology challenge current regulatory approaches and capacities. Since many of these issues parallel earlier debates on genetically modified foods, it seems highly likely that similar decision-making tools and approaches will be used for governing nano-based food. A key decision-making tool used by regulators in North America and Europe involves application of the principle of substantial equivalence. In this paper, the authors argue that substantial equivalence is an inapt arbiter of equivalence for nano-based food, and that it incorporates a fundamental flaw in logic known as a category-mistake.
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Substantial Equivalence

The principle of substantial equivalence first emerged in the 1990s when regulators were given the task of assessing the safety of genetically modified foods in a policy environment where specific biotechnology regulations and dedicated hazard and risk assessment tools had not yet been developed. This policy vacuum was quickly filled with competing ideas on how best to regulate products of biotechnology. At that time a choice existed for treating genetically modified foods similarly to other functional innovations such as novel chemical compounds including pesticides, food additives and pharmaceuticals (Millstone, Brunner & Mayer, 1999). Moreover, evidence-based research could have been developed and deployed to establish acceptable daily intakes (ADIs). Due to a general reluctance on the part of industry to carry out toxicological studies, and also because the very notion of establishing ADIs for genetically modified food implied restricting or limiting consumption, substantial equivalence was eventually adopted and embedded into policy statements of the Organization for Economic Cooperation and Development (OECD), United Nations Food and Agriculture Organization (FAO), and the World Health Organization (WHO).

Substantial equivalence is essentially a comparative approach. It is not a risk assessment but rather a hazard assessment tool for identifying possible problem areas (Kuiper et al., 2002). Hazard assessment involves identifying and controlling hazards, while risk assessment involves calculating the probability of a hazard generating adverse outcomes multiplied by the consequences associated with exposure. Consequently, risk assessment is part of a risk management approach, whereas hazard assessment is simply one of the input variables in the management of risk (Leiss, 2001). Since risk controversies - like those seen on the question of nuclear safety (Mehta, 2005) - involve contested concepts of risk acceptability, it should be no surprise to discover that public opposition to genetically modified food has focused on the criteria used for approving these products (Levidow, Murphy & Carr, 2007), and on labelling (Dannenberg, 2009). Clearly, several lessons need to be learned from this history when considering the likely trajectory that nanotechnology will follow as its introduction accelerates (Mehta, 2004; Frewer, 2010). Thus, sensitivity to consumer values (Vendermoere et al., 2009), general ethical considerations (Hunt & Mehta, 2006), preferences (Cobb & Macoubrie, 2004), and risk-benefit perceptions must become more central (Siegrist, Stampfli, & Kastenholtz, 2009). Additionally, there are strong arguments asserting that nano-based products represent a special case for application of the precautionary principle as a form of precautionary risk management and regulation (Clift, 2006).

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